Actively Recruiting
A Phase 1b, Open-label, Pilot Study of CLN-978 for the Treatment of Moderate to Severe Systemic Lupus Erythematosus (SLE)
Led by Cullinan Therapeutics Inc. · Updated on 2026-06-05
24
Participants Needed
20
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CLN-978, a subcutaneously administered CD19-directed T cell engager, in adults with moderate to severe Systemic Lupus Erythematosus (SLE). This Phase 1b open-label pilot study aims to assess the safety and tolerability of CLN-978 in patients who have active SLE with inadequate response to standard treatments, including corticosteroids, antimalarials, immunosuppressants, or biologics. The study is sponsored by Cullinan Therapeutics Inc. and plans to enroll adults aged 18 to 70 years. Participants will receive CLN-978 administered by subcutaneous injection in two parts: Part A involves dose escalation cohorts to determine safe dosing levels, and Part B further evaluates treatments at higher doses or extended schedules for eligible patients from Part A. The treatment duration includes up to 48 weeks of monitoring with specified dosing days. Patients must meet defined laboratory and disease activity criteria to participate, and those in Part B must have had no dose-limiting toxicity or treatment discontinuation in Part A and wait at least 90 days after the last dose. During the study, participants will undergo regular safety and tolerability assessments, including laboratory tests to monitor blood cell counts, kidney and liver function, and immune response markers. Pharmacokinetics, immunogenicity, and pharmacodynamics biomarkers related to treatment effects will also be evaluated over 48 weeks. The study aims to monitor adverse events closely and ensure ongoing assessment of treatment impact on disease activity and patient well-being throughout the trial.
CONDITIONS
Brief Title
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of SLE at least 24 weeks before screening and meeting 2019 EULAR / ACR Classification Criteria
- Presence of one or more autoantibodies: positive anti-nuclear antibody (ANA) test (≥1:80), anti dsDNA above upper limit of normal, or anti-Sm above upper limit of normal
- Active SLE disease with SLEDAI total score ≥6 at screening
- Inadequate response to at least two treatments including oral corticosteroids, antimalarials, conventional immunosuppressants, or biologics; at least one failed treatment must be immunosuppressive or biologic
- Stable dose of corticosteroid and/or antimalarial prior to day 1 if applicable
- Laboratory requirements: absolute lymphocyte count ≥0.5 x 10^9/L, peripheral B cell count ≥25 cells/μL, absolute neutrophil count ≥1.0 x 10^9/L, hemoglobin ≥8 g/dL, platelet count ≥75 x 10^9/L, estimated glomerular filtration rate ≥30 mL/min/1.73m2, total bilirubin ≤1.5 × upper limit of normal except Gilbert's Syndrome, AST and ALT ≤2.5 × upper limit of normal
- For Part B: patients treated in Part A without dose-limiting toxicity or discontinuation due to adverse events, eligible for retreatment at higher dose or longer schedule after at least 90 days since last dose
You will not qualify if you...
- Active inflammatory disease other than SLE, except thyroiditis or secondary Sjogren's syndrome
- Considered at high risk for thrombosis
- Rapidly progressive glomerulonephritis or urine protein/creatinine >3 mg/mg (339 mg/mmol)
- Active severe neuropsychiatric or central nervous system manifestations of SLE
- Evidence of hepatitis B, hepatitis C, HIV, Epstein-Barr virus, or cytomegalovirus infection
- History of splenectomy
- Prior treatment with cellular or gene therapy products targeting any target
- Investigational therapy use within 30 days or 5 drug-elimination half-lives before Day 1
- Anti-CD19 or anti-CD20 therapy within 3 months before Day 1
- Non-biologic DMARD within 14 days before Day 1
- Cyclophosphamide within 1 month or biologic immunomodulating therapy within 2 months before Day 1
- Live or attenuated vaccine within 28 days before or during screening
- Active significant infections including SARS-CoV-2 within 14 days before Day 1
- Active or latent tuberculosis unless previously treated and no current symptoms
- Any condition that may interfere with study assessments or patient safety as judged by Investigator or Sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants receive subcutaneous doses of CLN-978 with dose escalation and further dose evaluation to treat moderate to severe SLE.
Visits scheduled according to dose escalation and evaluation protocols
Trial Site Locations
Total: 20 locations
1
AARA Clinical Research
Avondale, Arizona, United States, 85392
Actively Recruiting
2
AARA Clinical Research
Tucson, Arizona, United States, 85704
Actively Recruiting
3
Omega Research Group
Orlando, Florida, United States, 32808
Actively Recruiting
4
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
5
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
6
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
7
Regional One Health
Memphis, Tennessee, United States, 38103
Actively Recruiting
8
Stryde Research
Plano, Texas, United States, 75093
Actively Recruiting
9
Tranquil Clinical Research
Webster, Texas, United States, 77598
Actively Recruiting
10
Intermountain Health
Salt Lake City, Utah, United States, 84101
Actively Recruiting
11
Royal Melbourne Hospital
Parkville, Australia, 3050
Actively Recruiting
12
Osteoporosis Solutions
Victoria Park, Australia, 6100
Actively Recruiting
13
Multi profile Hospital for Active Treatment Sveta Sofia
Sofia, Bulgaria, 1618
Actively Recruiting
14
CHU de Nantes
Nantes, France, 44093
Actively Recruiting
15
University Hospital Saint Etienne
Saint-Priest-en-Jarez, France, 42270
Actively Recruiting
16
Centre Hospitalier Universitaire de Toulouse
Toulouse, France, 31059
Actively Recruiting
17
ARENSIA Exploratory Medicine, LLC
Tbilisi, Georgia, 0112
Actively Recruiting
18
Timofei Moșneaga Republican Clinical Hospital
Chisinau, Moldova, 2025
Withdrawn
19
ARENSIA Exploratory Medicine S.R.L.
Bucharest, Romania, 011658
Actively Recruiting
20
Arensia Exploratory Medicine
Cluj-Napoca, Romania, 400006
Actively Recruiting
Research Team
M
Meagan Sardinha
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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